Safety and Efficacy Study of Association Between Tretinoin and Clindamycin on the Treatment of Acne Mild and Moderate

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and efficacy of association between tretinoin and clindamycin phosphate on the treatment of acne vulgaris mild and moderate.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Igefarma Laboratorios S.A.
• Treatments: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Tretinoin

Criteria

Inclusion Criteria:

• Individuals of both sexes with age greater than or equal to 12 years

• Subjects diagnosed with acne vulgaris in the face, except for the nasal area, range from mild to moderate, with the following requirements.

• Mild acne = presence of fewer than 20 comedones or less than 15 lesions, inflammatory lesions or a total of less than 30 injuries.

• Moderate acne = presence of 20 the 100 comedones or of 15 the 50 inflamatory lesions or a total of 30 the 125 lesions, with not more than lesions small nodule until 5,0 mm.

• Ensure that the existing injuries were not submitted any treatment for acne, topical or systemic, within the last 30 days.

• Be able to properly follow the determinations of the Protocol.

• Has provided a written voluntary consent to participate in the study, by signing the informed consent, before being subjected to any procedure.

• Under 18 years old, be accompanied by legal guardian in the process of obtaining the informed consent.

• Be mentally able to provide consent and be fulfilling all the requirements of the study.

Exclusion Criteria:

• Pregnant women or in periods of lactation.

• Women of childbearing age and sexual activity with not using safe contraceptive method, such as oral contraceptives, implantable, injectable or intra-uterine, introduced for at least 120 days.

• Women who are using oral contraceptives containing the hormone combination for acetate ciprosterone and etinolestradiol, association of drospirenone and ethinyl estradiol, or desogestrel.

• Clinical evidence or history of immunodeficiency.

• Any use of immunosuppressive drug and/or immunomodulating over the past 3 months, topical or systemic.

• Concurrent use of fotossentetizadores, neuromuscular blockers, medications that exacerbate the acne, blockers (filters) with solar alcoholic vehicle, spironolactone, flutamide or zinc salts.

• Prior use of systemic retinoid.

• Presence of acne medication and/or cosmetic.

• History of systemic metabolic disorder that can interfere with the integrity of the skin.

• History of inflammatory disease, intestinal or regional enteritis and/or symptoms similar.

• History of joy to any of the components of the formula (active principle or carrier).

• History of abuse of alcohol and/or illegal drugs.

• History of non-adherence to medical treatment earlier.

• Any clinical observation made by the investigator that prohibits participation in the study of the subject.